1. Field of the Invention
The present invention relates to estrogenic effects in the human body. More particularly, the present invention relates to the utilization of a dietary composition or supplement to selectively inhibit estrogen production and to provide estrogenic effects in the human body, wherein the composition is formulated with one or more processed products from the Indian Mulberry plant, scientifically known as Morinda citrifolia L. 
2. Background and Related Art
Estrogens or oestrogens are steroid hormones produced chiefly by the ovaries and are responsible for promoting estrus and for the development and maintenance of female sexual characteristics. In humans, oestrogen is formed in the ovary, possibly the adrenal cortex, the testis, and the foetoplacental unit. Estrogens or oestrogens have various functions. For example, they are responsible for the development of the female secondary sex characteristics and during the menstrual cycle they act on the female genitalia to produce an environment suitable for the fertilization, implantation and nutrition of the early embryo.
Estrogen is produced from an enzyme called aromatase, which is part of an enzyme complex known as Cytochrome P450 that exists in different parts of the body, and particularly within several major organs. The aromatase enzyme in the human body is expressed in the placenta, adipose tissues, hair follicles, muscles, bones, liver and the brain. In the brain, aromatase can be found in the anterior and mediobasal hypothalamus.
Aromatase specializes in converting C19 androgens to aromatic C18 estrogenic steroids. However, aromatase also has the ability to metabolize xenobiotics. The ability or function of aromatase to convert adrenal androgen substrates into estrogens accounts for the sole source of estrogen in postmenopausal women. Therefore, inhibitors of the aromatase enzyme are used to treat postmenopausal breast cancer and other estrogen-dependent diseases.
Only recently have aromatase inhibitors begun to be recognized as a viable treatment option for breast cancer and other estrogen-dependent diseases. As such, use of these inhibitors continues to gain momentum. Aromatase inhibitors belong to a family of hormonal treatments that have been shown in the laboratory, as well as in several clinical trials, to produce significant anti-cancerous activity in relation to breast cancer that is discovered in post-menopausal women. Aromatase inhibitors are especially advantageous or effective in cases where a woman exhibits or possesses greater estrogen-sensitivity.
In has been established and is widely believed that more than two thirds of breast cancer cases are considered “estrogen sensitive” because they are able to grow and proliferate throughout the mammary region and beyond. In response, and to prevent this overgrowth, aromatase inhibitors are introduced, which reduce the amount of circulating estrogen in post-menopausal women, thus causing the estrogen-sensitive or estrogen dependant tumors to stop growing and even shrink. Estrogen sensitive cancers are also known as ER+(estrogen-receptor positive) and are referred to by others as progesterone-receptor positive (PR+).
Cancerous or tumor cells each have receptors (docking places) located on their cell membrane. As estrogen is produced and released into the body, it binds to these cell receptors. Therefore, in determining the efficacy of inhibitory treatments, it is possible to measure each receptor and its binding efficiency with estrogen. This binding efficiency is commonly referred to as “receptor status.” Concomitantly, receptor status becomes an invasive part of the prognosis of breast cancer.
Many aromatase inhibitors inhibit the receptors from binding with estrogen, while others inhibit the actual aromatase enzymes that function to convert androgens to estrogens. In addition, aromatase inhibitors lower estrogen more effectively after menopause because in menopause, both ovaries stop producing estrogen. However, that is not to say that no amount of estrogen is produced in the body. The low level of estrogen that is produced after menopause is a result of the aromatase enzymes converting other naturally occurring hormones into estrogen. As such, aromatase inhibitors were developed to effectively prevent aromatase enzymes from being used to produce estrogen. As a result, estrogen levels in the body fall, and estrogen-dependent tumors begin to or are more likely to shrink and digress. In contradistinction, before menopause, estrogen is mainly produced in the ovaries, with only a small amount being produced from the aromatase process. Numerous studies have indicated that aromatase inhibitors do not lower estrogen levels enough in premenopausal women to affect tumor growth.
Currently, there are a very limited number of aromatase inhibitors that are actually in use and that have been approved by the Food and Drug Administration. Some of the more widely used inhibitors are Arimidex®, Aromasin®, and Femara,® which have all gone through several clinical trials. Although effective at performing their intended function of inhibiting the aromatase enzymes, these inhibitors induce numerous undesirable side effects in the patient, thus making their treatment less popular and less desirable. Interestingly enough, these approved treatments for postmenopausal women consist of drugs that block estrogen receptors on the surface of tumor cells and are either reversible or irreversible. However, their side effects consist of, but are not limited to, sweating, hot flashes, fatigue, appetite changes, headaches, bone pain, chest pain, coughing, shortness of breath, and in some patients, blood clots.
Techniques also exist for the harvesting of estrogens or oestrogens for increasing the level of estrogen located in the human body. Such techniques include harvesting them from the urine of pregnant horses. While this technique is available, a number of side effects exist, including such similar side effects as sweating, hot flashes, fatigue, appetite changes, headaches, bone pain, chest pain, coughing, shortness of breath, and the like. Accordingly, great efforts are being made by research and development groups in hopes to obtain an improved harvesting technique and/or an improved composition that produces a safer estrogen hormone for utilization in the body.
Thus, while techniques currently exist that are used to inhibit estrogen production and to harvest estrogen for utilization in the body, challenges still exist, including such undesirable side effects as sweating, hot flashes, fatigue, appetite changes, headaches, bone pain, chest pain, coughing, shortness of breath, and the like. Accordingly, it would be an improvement in the art to augment or even replace current techniques with other techniques.